Industry: Orthopaedic AND Dental.
Job Title: Scheme Manager - Formulation Manager - Technical Specialist - Medical Device Expert - Certification Manager - Project Manager - Design Control Manager - Formulation Manager - Product Development Manager - R&D Manager
Location: Home/Office based UK.
Salary: 50-65k depending on experience.
Training: Yes (Full).
Today you are working from home reviewing fatigue test data on a new drug eluting stent design of one of your customers. Tomorrow you audit the manufacturing facilities of a large manufacturer of Drug Delivery or Combination products in the UK or Germany. Next week you present at a medical device regulatory conference in Sweden. As A Technical Lead, Scheme manager, Product expert and part of one of our global technology teams, you appreciate the dynamic of working in a mix of regulatory affairs, quality auditing and medical technology innovations. You enjoy an international working environment in a growing team of medical device experts, working with small start-up and large multi-national clients, a bit of travelling and reviewing the latest technologies.
Requirement: Currently recruiting Medical Device Technical Experts for the Orthopaedic and Dental Team in the following device categories:
Orthopaedic implants (specifically large and / or small joint replacement implants); Dental implants (titanium screw implants or Guided Tissue Regeneration implants); Bone void fillers (synthetic and / or biologic); General orthopaedic & non-active devices.
Function of the position:
- As a technical expert assessing the manufacturer's technical files and design dossiers;
- As a member of a team auditing a device manufacturer's quality system;
- As a regulatory expert and scheme manager, managing a portfolio of clients with respect to services provides to them.
- Provide specialist pharmaceutical affairs, regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes;
- Deliver technical reviews and certification scheme management in support of CE marking;
- Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to pharmaceuticals;
- Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel; and to
- Provide in-house and external training for device/drug combination products.
Team members have overall client management responsibilities and will be competent to review critical design data (including risk analysis, labeling, clinical investigation data and post market surveillance information) and to prepare recommendations for CE certification.
Qualifications and Experience:
Candidates will have medical device experience within an industrial, academic or clinical background.
Their qualifications will reflect a thorough understanding of the technological considerations and manufacturing processes relevant to the field in which they have worked.
Successful candidates will be motivated to perform detailed investigation of complex technical issues, have a desire to learn new disciplines, are strong communicators, and have strong analytical and organizational skills, and have the presence to make and explain difficult decisions if necessary.
IMPLANTS / DENTAL / REGENERATOIN / JOINTS / BONE / SYNTHETIC / TISSUE / REVIEWER / IMPLANTABLES / AIMD / SOFT TISSUE / MECHANICAL / QA / QMS / QUALITY MANAGEMENT / QUALITY ASSURANCE / ISO13485 / FDA / 21 CFR / 2001/82/EC / BIOCOMPATIBILITY / RISK ASSESSMENT / TECHNICAL REVIEWER / SCHEME MANAGER / TECHNICAL MANAGER / VALIDATION / VERIFICATION / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / BOSTON SCIENTIFIC / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / SWEDEN / DENMARK / BENELUX, BELGIUM, SWITZERLAND, FRANCE, GERMAN / ENGLAND / US / USA / AMERICA / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / SCHOTTLANDER / DAMAS / MR DENTAL / PSP / KARL STORZ / TUV / SGS / BSI / LRQA / KEMA / DEKRA / MEDPASS / APATEC / INTERTEK / UL / UNIVERSAL LABORATORIES / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / BOSTON SCIENTIFIC / ACELITY / CONVATEC / SYSTAGENIX / DEPUY / SMITH NEPHEW / COVIDIEN / BAXTER / BIOMEDICAL / BIOMET / SMITH NEPHEW / MEDTRONIC / STRYKER / SWEDEN / AUSTRIA / BELGIUM / FRANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / COOPERVISION / SAUFLON / BAXTER / BBRAUN / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / / CAREFUSION / SIEMENS / PHILIPS / SGS / LRQA / LGE / BUREAU VERITAS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / BIOMET / LOMBARD / MEDICAL / BIOMEDICAL / VARIAN / SUPERSONIC / MEDTRONIC / TISSUE REGENIX / SCIENTIFIC / SCIENCE / CLINICAL / PROJECT MANAGEMENT / PROJECT MANAGER / CRO /SSL/MOLYNCKE/SURGICAL / SCIENTIFIC / FORMULATION / CE MARKING / CERTIFICATION / USA / UK / UNITED KINGDOM /TISSUE SCIENCE/ JOHNSON/SIGVARIS/COLOPLAST/GEM/BSN/B BRAUN / HOLLISTER / TECHNICAL ASSESSOR / PRODUCT EXPERT / PRODUCT SPECIALIST / CONSULTANT / PRODUCT ASSESSOR / SCHEME MANAGER
- Medical Devices
- Technical Specialists
- Product Specialists
- life science
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